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Subclinical leaflet thrombosis (SLT) is characterized on computed tomography (CT) imaging as hypoattenuated leaflet thickening (HALT), reduced leaflet motion (RELM), and hypoattenuation affecting motion (HAM). How antithrombotic regimen type impacts SLT remains poorly understood. We evaluated how antithrombotic regimen type impacts SLT in low-risk subjects following transcatheter aortic valve implantation (TAVI).This substudy is a post hoc analysis of the LRT 1.0 and 2.0 trials to assess SLT in subjects who underwent CT or transoesophageal echocardiogram (TOE) imaging at 30 days, stratified by antithrombotic regimen received (single antiplatelet therapy [SAPT], dual antiplatelet therapy [DAPT], or oral anticoagulation). We also utilized univariable logistic regression modelling to identify echocardiographic predictors of HALT.Rates of HALT, RELM, and HAM were all significantly lower with oral anticoagulation compared to SAPT or DAPT at 30 days (HALT: 2.6% vs 14.3% vs 17.2%, respectively, with p 0.001; RELM: 1.8% vs 9.6% vs 13.1%, respectively, with p = 0.004; and HAM: 0.9% vs 8.5% vs 9.8%, respectively, with p = 0.011). Additionally, short-term oral anticoagulation was not associated with higher bleeding rates compared to SAPT or DAPT (0.8% vs. 1.8% vs. 3.6%, p = 0.291). The presence of HALT did not significantly impact echocardiographic haemodynamic parameters at 30 days.This is the largest study to date that evaluated the impact of different antithrombotic regimens on SLT in low-risk TAVI patients. Oral anticoagulation was associated with significantly lower rates of SLT at 30 days compared to DAPT or SAPT, and there was no apparent benefit of DAPT over SAPT.

The present study sought to understand the antecedents to COVID-19 vaccination among those reporting a change in vaccine intention in order to improve COVID-19 vaccine uptake in the United States. We employed semi-structured interviews and one focus group discussion with vaccinated and unvaccinated Veterans Health Administration (VHA) employees and Veterans at three Veterans' Affairs medical centers between January and June 2021. A subset of these participants (n=21) self-reported a change in COVID-19 vaccine intention and were selected for additional analysis. We combined thematic analysis using the 5C scale (confidence, collective responsibility, complacency, calculation, constraints) as our theoretical framework with a constant comparative method from codes based on the SAGE Working Group on Vaccine Hesitancy. We generated 13 themes distributed across the 5C constructs that appeared to be associated with a change in COVID-19 vaccine intention. Themes included a trusted family member, friend or colleague in a healthcare field, a trusted healthcare professional, distrust of government or politics (confidence); duty to family and protection of others (collective responsibility); perceived health status and normative beliefs (complacency); perceived vaccine safety, perceived risk-benefit, and orientation towards deliberation (calculation); and ease of process (constraints). Key factors in promoting vaccine uptake included a desire to protect family; and conversations with as key factors in promoting vaccine uptake. Constructs from the 5C scale are useful in understanding intrapersonal changes in vaccine intentions over time, which may help public health practitioners improve future vaccine uptake.In this study of the Veteran and VA employee population, we aimed to understand what factors led to a decision to receive a COVID-19 vaccine. As part of a quality improvement project, we interviewed individuals at three Veterans’ Affairs sites in the first six months of 2021. We then used a smaller sample of 21 participants who reported a change in their intentions to receive a COVID-19 vaccine to analyze for this study. This analysis utilizes constructs from the 5C scale, which was developed to understand the conditions required for an individual to decide to receive a vaccine (confidence, collective responsibility, complacency, calculation, constraints). The coding process revealed a number of recurring themes across the interviews falling under each of the five constructs, but concepts relating to vaccine confidence (i.e., level of trust in those developing and disseminating the vaccine) were most common, and constraints (i.e., psychological and structural barriers that stand in the way of vaccination) appeared least frequently in our interviews. We found that significant motivators to receive the vaccine included a desire to protect family and conversations with trusted clinicians, particularly mental healthcare providers. Our study was unique in using the 5Cs to understand changes in vaccine changes over time. Findings show that change in vaccine attitudes is possible even in the presence of concerns and shed light on approaches that public health providers could use to improve vaccine and booster rates.

To identify which Veteran populations are routinely accessing video-based care.National, secondary administrative data from electronic health records at the Veterans Health Administration (VHA), 2019-2021.This retrospective cohort analysis identified patient characteristics associated with the odds of using any video care; and then, among those with a previous video visit, the annual rate of video care utilization. Video care use was reported overall and stratified into care type (e.g., primary, mental health, and specialty video care) between March 10, 2020 and February 28, 2021.Veterans active in VA health care (1 outpatient visit between March 11, 2019 and March 10, 2020) were included in this study.Among 5,389,129 Veterans in this evaluation, approximately 27.4% of Veterans had at least one video visit. We found differences in video care utilization by type of video care: 14.7% of Veterans had at least one primary care video visit, 10.6% a mental health video visit, and 5.9% a specialty care video visit. Veterans with a history of housing instability had a higher overall rate of video care driven by their higher usage of video for mental health care compared with Veterans in stable housing. American Indian/Alaska Native Veterans had reduced odds of video visits, yet similar rates of video care when compared to White Veterans. Low-income Veterans had lower odds of using primary video care yet slightly elevated rates of primary video care among those with at least one video visit when compared to Veterans enrolled at VA without special considerations.Variation in video care utilization patterns by type of care identified Veteran populations that might require greater resources and support to initiate and sustain video care use. Our data support service specific outreach to homeless and American Indian/Alaska Native Veterans.

INTRODUCTION/AIMS: In prior work, higher quality care for work-associated carpal tunnel syndrome (CTS) was associated with improved symptoms, functional status, and overall health. We sought to examine whether quality of care is associated with healthcare expenditures or disability. METHODS: Among 343 adults with workers’ compensation claims for CTS, we created patient-level aggregate quality scores for underuse (not receiving highly beneficial care) and overuse (receiving care for which risks exceed benefits). We assessed whether each aggregate quality score (0-100%, 100% = better care) was associated with healthcare expenditures (18-month expenditures, any anticipated need for future expenditures) or disability (days on temporary disability, permanent impairment rating at 18 months). RESULTS: Mean aggregate quality scores were 77.8% (standard deviation [S.D.] 16.5%) for underuse and 89.2% (S.D. 11.0%) for overuse. An underuse score of 100% was associated with higher risk-adjusted 18-month expenditures ($3,672; 95% CI $324 to $7,021) but not with future expenditures (−0.07 percentage points; 95% CI −0.48 to 0.34), relative to a score of 0%. An overuse score of 100% was associated with lower 18-month expenditures (−$4,549, 95% CI −$8,792 to −$306) and a modestly lower likelihood of future expenditures (−0.62 percentage points, 95% CI −1.23 to −0.02). Quality of care was not associated with disability. DISCUSSION: Improving quality of care could increase or lower short-term healthcare expenditures, depending on how often care is currently underused or overused. Future research is needed on quality of care in varied workers’ compensation contexts, as well as effective and economical strategies for improving quality.

Limited implementation of palliative care practices in hemodialysis may contribute to end-of-life care that is intensive and not patient centered. We determined whether a learning collaborative for hemodialysis center providers improved delivery of palliative care best practices.Ten US hemodialysis centers participated in a pre-post study targeting seriously ill patients between April 2019 and September 2020. Three practices were prioritized: screening for serious illness, goals of care discussions, and use of a palliative dialysis care pathway. The collaborative educational bundle consisted of learning sessions, communication skills training, and implementation support. The primary outcome was change in the probability of complete advance care planning documentation among seriously ill patients. Health care utilization was a secondary outcome, and implementation outcomes of acceptability, adoption, feasibility, and penetration were assessed using mixed methods.One center dropped out due to the coronavirus disease 2019 pandemic. Among the remaining nine centers, 20% (273 of 1395) of patients were identified as seriously ill preimplementation, and 16% (203 of 1254) were identified as seriously ill postimplementation. From the preimplementation to postimplementation period, the adjusted probability of complete advance care planning documentation among seriously ill patients increased by 34.5 percentage points (95% confidence interval, 4.4 to 68.5). There was no difference in mortality or in utilization of palliative hemodialysis, hospice referral, or hemodialysis discontinuation. Screening for serious illness was widely adopted, and goals of care discussions were adopted with incomplete integration. There was limited adoption of a palliative dialysis care pathway.A learning collaborative for hemodialysis centers spanning the coronavirus disease 2019 pandemic was associated with adoption of serious illness screening and goals of care discussions as well as improved documentation of advance care planning for seriously ill patients.Pathways Project: Kidney Supportive Care, NCT04125537.

Occurrences of physician burnout have reached epidemic numbers, and the electronic health record (EHR) is a commonly cited cause of the distress. To enhance current understanding of the relationship between burnout and the EHR, we explored the connections between physicians' distress and the EHR.In this qualitative study, physicians and graduate medical trainees from two healthcare organizations in California were interviewed about EHR-related distressing events and the impact on their emotions and actions. We analyzed physician responses to identify themes regarding the negative impact of the EHR on physician experience and actions. EHR "distressing events" were categorized using the Accreditation Council for Graduate Medical Education (ACGME) Physician Professional Competencies.Every participating physician reported EHR-related distress affecting professional activities. Five main themes emerged from our analysis: system blocks to patient care; poor implementation, design, and functionality of the EHR; billing priorities conflicting with ideal workflow and best-practice care; lack of efficiency; and poor teamwork function. When mapped to the ACGME competencies, physician distress frequently stemmed from situations where physicians prioritized systems-based practice above other desired professional actions and behaviors. Physicians also reported a climate of silence in which physicians would not share problems due to fear of retribution or lack of confidence that the problems would be addressed.Physicians and administrators need to address the hierarchy of values that prioritizes system requirements such as those required by the EHR above physicians' other desired professional actions and behaviors. Balancing the importance of competing competencies may help to address rising burnout. We also recommend that administrators consider qualitative anonymous interviews as an effective method to uncover and understand physician distress in light of physicians' reported climate of silence.

Spontaneous coronary artery dissection (SCAD) is a potential precipitant of myocardial infarction and sudden death for which the etiology is poorly understood. Mendelian vascular and connective tissue disorders underlying thoracic aortic disease (TAD), have been reported in ~5% of individuals with SCAD. We therefore hypothesized that patients with TAD are at elevated risk for SCAD. We queried registries enrolling patients with TAD to define the incidence of SCAD. Of 7568 individuals enrolled, 11 (0.15%) were found to have SCAD. Of the sequenced cases (9/11), pathogenic variants were identified (N = 9), including COL3A1 (N = 3), FBN1 (N = 2), TGFBR2 (N = 2), TGFBR1 (N = 1), and PRKG1 (N = 1). Individuals with SCAD had an increased frequency of iliac artery dissection (25.0% vs. 5.1%, p = 0.047). The prevalence of SCAD among individuals with TAD is low. The identification of pathogenic variants in genes previously described in individuals with SCAD, particularly those underlying vascular Ehlers–Danlos, Marfan syndrome, and Loeys–Dietz syndrome, is consistent with prior reports from clinical SCAD series. Further research is needed to identify specific genetic influences on SCAD risk.

To identify trends in transcatheter aortic valve replacement (TAVR) use and outcomes by race (non-Hispanic White, Black), ethnicity (Hispanic), and sex over time.Despite rapid growth in TAVR use over time, our understanding of its use and outcomes among males and females of underrepresented racial/ethnic groups remains limited.A retrospective analysis of hospitalizations from 2013 to 2017 from the Healthcare Cost and Utilization Project database was performed.White patients comprised 65% (n = 2.16 × 10Differences in TAVR growth and outcomes by race, ethnicity, and sex over time highlight areas for focused efforts to close gaps in minimally invasive structural heart disease care.

Background: Although the assessment of right ventricular (RV) diastolic function is feasible, it has garnered far less momentum for use compared with its left ventricular counterpart. The scarcity of data defining normative RV diastolic function and the fact that implications of RV diastolic dysfunction in different disease states on outcomes are less well known both hinder integration into routine clinical assessment. The aim of this study was to establish normal values of RV diastolic parameters stratified by sex, age, and race using data from the World Alliance Societies of Echocardiography study. Methods: A subset of 888 normal subjects from the World Alliance Societies of Echocardiography database were analyzed, including measurements of tricuspid valve (TV) inflow E- and A-wave velocities, E-wave deceleration time, and TV annular tissue Doppler e′ and a′ velocities. Additionally, right atrial (RA) maximal volume and RA peak reservoir strain were measured. Patients were grouped by age ([removed]65 years) and stratified by sex and race. Differences were analyzed using unpaired t tests. Results: Compared with men, women had significantly higher TV e′ and E-wave and A-wave velocities, though differences were modest. Increasing age was associated with stepwise lower TV E wave, e′ velocity, and TV E/A ratio and higher a′ velocity and E/e′ ratio. RA peak reservoir strain was also lower, and RA end-systolic volume trended toward being smaller for older age groups. Asian subjects demonstrated significantly higher a′ velocities, lower E wave, the smallest RA end-systolic volumes, and the lowest RA peak strain values compared with white subjects of both sexes. Conclusions: This study provides normal values for parameters used in the assessment of RV diastolic function stratified by race, sex, and age. The results demonstrate significant differences in RV diastolic parameters between age groups, which manifest in both individual parameters and composite ratios of TV inflow and annular velocities. Although limited sex- and race-related differences were also noted, age appears to have the most significant impact on RV diastolic parameters. These findings may aid in refining current normative values.

Background: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years. Methods: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years. Results: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm 2 ) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; P =0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years. Conclusions: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02628899.

Background: Patient-reported outcomes (PROs) may improve care for patients with heart failure. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a patient survey that captures symptom frequency, symptom burden, physical limitations, social limitations, and quality of life. Despite the utility of PROs and the KCCQ-12, the implementation and routine use of these measures can be difficult. We conducted an evaluation of clinician perceptions of the KCCQ-12 to identify barriers and facilitators to implementation into clinical practice. Methods: We conducted interviews with cardiologists from 4 institutions across the United States and Canada (n=16) and observed clinic visits at 1 institution in Northern California (n=5). Qualitative analysis was conducted in 2 rounds: (1) rapid analysis constructed around major themes related to the aims of the study and (2) content analysis with codes derived from the rapid analysis and implementation science. Results: Most heart failure physicians and advanced practice clinicians reported that the KCCQ-12 was acceptable, appropriate, and useful in clinical care. Clinician engagement efforts, trialability, and the straightforward design of the KCCQ-12 facilitated its use in clinical care. Further opportunities identified to facilitate implementation include more streamlined integration into the electronic health record and comprehensive staff education on PROs. Participants highlighted that the KCCQ-12 was useful in clinic visits to improve the consistency of patient history taking, focus patient-clinician conversations, collect a more accurate account of patient quality of life, track trends in patient well-being over time, and refine clinical decision-making. Conclusions: In this qualitative study, clinicians reported that the KCCQ-12 enhanced several aspects of heart failure patient care. Use of the KCCQ-12 was facilitated by a robust clinician engagement campaign and the design of the KCCQ-12 itself. Future implementation of PROs in heart failure clinic should focus on streamlining electronic health record integration and providing additional staff education on the value of PROs. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT04164004.

BackgroundRight ventricular (RV) functional assessment is mainly limited to its longitudinal component. However, due to the complex orientation of the myofibers, the RV contraction involves coordinated motion along multiple planes. Recently developed 3-dimensional echocardiography (3DE) software has enabled the separate assessment of the non-longitudinal components of RV systolic function and their relative contribution to RV performance. The aims of this study were 1) to establish normal values for 3D-derived longitudinal, radial, and anteroposterior RV ejection fraction (LEF, REF, AEF respectively) and their relative contributions to global RVEF, 2) to calculate 3D RV strain normal values and, 3) to determine sex, age and race related differences in these parameters in a large group of normal subjects (WASE study)Methods1043 healthy adult subjects prospectively enrolled at 17 centers in 15 countries were used in this study. 3DE RV wide-angle datasets were analyzed to generate a 3D mesh model of the RV cavity (TomTec). Then, dedicated software (ReVISION) was used to analyze RV motion along the three main anatomical planes and the ejection fraction (EF) values corresponding to each plane were identified as LEF, REF, and AEF. Relative contributions were determined by dividing each EF component by the global RVEF. RV strain analysis included longitudinal, circumferential, and global area strains (GLS, GCS and GAS, respectively). Results were categorized by sex, age (18-40, 41-65 and >65 years), and race.ResultsAbsolute REF, AEF, LEF and global RVEF were higher in women than in men (p < .001). With aging, both sexes exhibited a decline in all the determinants of longitudinal shortening (p Conclusion3DE evaluation of the non-longitudinal components of RV contraction provides additional information regarding RV physiology, including sex, age and race - related differences in RV contraction patterns that may prove useful in disease states involving the RV.

Background COVID-19 infection is known to cause a wide array of clinical chronic sequelae, but little is known regarding the long-term cardiac complications. We aim to report echocardiographic follow-up findings and describe the changes in left (LV) and right ventricular (RV) function that occur following acute infection. Methods Patients enrolled in the World Alliance Societies of Echocardiography-COVID study with acute COVID-19 infection were asked to return for a follow-up transthoracic echocardiogram. Overall, 198 returned at a mean of 129 days of follow-up, of which 153 had paired baseline and follow-up images that were analyzable, including LV volumes, ejection fraction (LVEF), and longitudinal strain (LVLS). Right-sided echocardiographic parameters included RV global longitudinal strain, RV free wall strain, and RV basal diameter. Paired echocardiographic parameters at baseline and follow-up were compared for the entire cohort and for subgroups based on the baseline LV and RV function. Results For the entire cohort, echocardiographic markers of LV and RV function at follow-up were not significantly different from baseline (all P > .05). Patients with hyperdynamic LVEF at baseline (>70%), had a significant reduction of LVEF at follow-up (74.3% ± 3.1% vs 64.4% ± 8.1%, P < .001), while patients with reduced LVEF at baseline (−20%) at baseline had significant improvement at follow-up (−15.2% ± 3.4% vs −17.4% ± 4.9%, P = .004). Patients with abnormal RV basal diameter (>4.5 cm) at baseline had significant improvement at follow-up (4.9 ± 0.7 cm vs 4.6 ± 0.6 cm, P = .019). Conclusions Overall, there were no significant changes over time in the LV and RV function of patients recovering from COVID-19 infection. However, differences were observed according to baseline LV and RV function, which may reflect recovery from the acute myocardial injury occurring in the acutely ill. Left ventricular and RV function tends to improve in those with impaired baseline function, while it tends to decrease in those with hyperdynamic LV or normal RV function.

Background The goal of this study was an assessment of availability postoperative pain management quality measures and National Quality Forum–endorsed measures. Postoperative pain is an important clinical timepoint because poor pain control can lead to patient suffering, chronic opiate use, and/or chronic pain. Quality measures can guide best practices, but it is unclear whether there are measures for managing pain after surgery. Methods The National Quality Forum Quality Positioning System, Agency for Healthcare Research and Quality Indicators, and Centers for Medicare and Medicaid Services Measures Inventory Tool databases were searched in November 2019. We conducted a systematic literature review to further identify quality measures in research publications, clinical practice guidelines, and gray literature for the period between March 11, 2015 and March 11, 2020. Results Our systematic review yielded 1,328 publications, of which 206 were pertinent. Nineteen pain management quality measures were identified from the quality measure databases, and 5 were endorsed by National Quality Forum. The National Quality Forum measures were not specific to postoperative pain management. Three of the non-endorsed measures were specific to postoperative pain. Conclusion The dearth of published postoperative pain management quality measures, especially National Quality Forum–endorsed measures, highlights the need for more rigorous evidence and widely endorsed postoperative pain quality measures to guide best practices.

BackgroundCardiovascular procedural treatments were deferred at scale during the COVID-19 pandemic, with unclear impact on patients presenting with Non-ST Elevation Myocardial Infarction (NSTEMI).MethodsIn a retrospective cohort study of all patients diagnosed with NSTEMI in the U.S. Veterans Affairs Healthcare System from 1/1/19 to 10/30/22 (n=67,125), procedural treatments and outcomes were compared between the pre-pandemic period and six unique pandemic phases (1: Acute phase, 2: Community spread, 3: First Peak, 4: Post-Vaccine, 5. Second Peak, 6. Recovery). Multivariable regression analysis was performed to assess association between pandemic phases and 30-day mortality.ResultsNSTEMI volumes dropped significantly with the pandemic onset (62.7% of pre-pandemic peak) and did not revert to pre-pandemic levels in subsequent phases, even after vaccine availability. Percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG) volumes declined proportionally. Compared to the pre-pandemic period, NSTEMI patients experienced higher 30-day mortality during Phase 2 and 3, even after adjustment for COVID-19 positive status, demographics, baseline comorbidities, and receipt of procedural treatment (adjusted OR for Phase 2-3 combined: 1.26 [95% CI 1.13-1.43], pConclusionsHigher mortality after NSTEMI occurred during the initial spread and first peak of the pandemic, but resolved before the second, higher peak – suggesting effective adaptation of care delivery but a costly delay to implementation. Investigation into the vulnerabilities of the early pandemic spread are vital to informing future resource-constrained practices.Clinical PerspectiveWhat is New?After the initial significant decline in NSTEMI presentations during the acute phase of the pandemic, volumes of NSTEMI presentations and procedural treatment have not reverted to pre-pandemic levels despite widespread availability of vaccines in the Veterans Health Administration.Compared to the pre-pandemic period, 30-day mortality after NSTEMI increased during the initial spread and first pandemic peak (Phases 2 and 3) -- but resolved before the subsequent highest pandemic peak of Phase 5 -- suggesting a delay to implementation of adapted systems of cardiovascular care.The increased mortality was not significantly mediated by the decline in procedural volumes, suggesting appropriate triage of procedural care during the pandemic.What are the Clinical Implications?The COVID-19 pandemic appears to have had a lasting impact on health-seeking behaviors among NSTEMI patients, with unclear long-term effects of this increased threshold to obtain cardiovascular care.Investigation into the vulnerabilities that occurred during initial phases of the pandemic are urgently needed to inform ongoing and future resource-constrained practices.

Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge‐to‐edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge‐to‐edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel‐controlled, open‐label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II–IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end‐systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge‐to‐edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870 ; NCT04198870.

Background: Although increased left ventricular (LV) mass is associated with adverse outcomes, measured values vary widely depending on the specific technique used. Moreover, the impact of sex, age, and race on LV mass remains controversial, further limiting the clinical use of this parameter. Accordingly, the authors studied LV mass using a variety of two-dimensional and three-dimensional echocardiographic techniques in a large population of normal subjects encompassing a wide range of ages. Methods: Transthoracic echocardiograms obtained from 1,854 healthy adult subjects (52% men) enrolled in the World Alliance Societies of Echocardiography (WASE) Normal Values Study, were divided into three age groups (young, 18-35 years; middle aged, 36-55 years; and old, >55 years). LV mass was obtained using five conventional techniques, including linear and two-dimensional methods, as well as direct three-dimensional measurement. All LV mass values were indexed to body surface area, and differences according to sex, age, and race were analyzed for each technique. Results: LV mass values differed significantly among the five techniques. Three-dimensional measurements were considerably smaller than those obtained using the other techniques and were closer to magnetic resonance imaging normal values reported in the literature. For all techniques, LV mass in men was significantly larger than in women, with and without body surface area indexing. These technique- and sex-related differences were larger than measurement variability. In women, age differences in LV mass were more pronounced and depicted significantly larger values in older age groups for all techniques, except three-dimensional echocardiography, which showed essentially no differences. LV mass was overall larger in black subjects than in white or Asian subjects. Conclusions: Significant differences in LV mass values exist across echocardiographic techniques, which are therefore not interchangeable. Sex-, race-, and age-related differences underscore the need for separate population specific normal values.

Aims Aortic valve area (AVA) used for echocardiographic assessment of aortic stenosis (AS) has been traditionally interpreted independently of sex, age and race. As differences in normal values might impact clinical decision-making, we aimed to establish sex-, age- and race-specific normative values for AVA and Doppler parameters using data from the World Alliance Societies of Echocardiography (WASE) Study. Methods and results Two-dimensional transthoracic echocardiographic studies were obtained from 1903 healthy adult subjects (48% women). Measurements of the left ventricular outflow tract (LVOT) diameter and Doppler parameters, including AV and LVOT velocity time integrals (VTIs), AV mean pressure gradient, peak velocity, were obtained according to ASE/EACVI guidelines. AVA was calculated using the continuity equation. Compared with men, women had smaller LVOT diameters and AVA values, and higher AV peak velocities and mean gradients (all P < 0.05). LVOT and AV VTI were significantly higher in women (P < 0.05), and both parameters increased with age in both sexes. AVA differences persisted after indexing to body surface area. According to the current diagnostic criteria, 13.5% of women would have been considered to have mild AS and 1.4% moderate AS. LVOT diameter and AVA were lower in older subjects, both men and women, and were lower in Asians, compared with whites and blacks. Conclusion WASE data provide clinically relevant information about significant differences in normal AVA and Doppler parameters according to sex, age, and race. The implementation of this information into clinical practice should involve development of specific normative values for each ethnic group using standardized methodology.

Background: Normal values for three-dimensional (3D) right ventricular (RV) size and function are not well established, as they originate from small studies that involved predominantly white North American and European populations, did not use RV-focused views, and relied on older 3D RV analysis software. The World Alliance Societies of Echocardiography study was designed to generate reference ranges for normal subjects around the world. The aim of this study was to assess the worldwide capability of 3D imaging of the right ventricle and report size and function measurements, including their dependency on age, sex, and ethnicity. Methods: Healthy subjects free of cardiac, pulmonary, and renal disease were prospectively enrolled at 19 centers in 15 countries, representing six continents. Three-dimensional wide-angle RV data sets were obtained and analyzed using dedicated RV software (TomTec) to measure end-diastolic volume (EDV), end-systolic volume (ESV), stroke volume, and ejection fraction (EF). Results were categorized by sex, age (18-40, 41-65, and >65years) and ethnicity. Results: Of the 2,007 subjects with attempted 3D RV acquisitions, 1,051 had adequate image quality for confident measurements. Upper and lower limits for body surface area-indexed EDV, ESV, and EF were 48 and 95 mL/m2, 19 and 43 mL/m2, and 44% and 58%, respectively, for men and 42 and 81 mL/m2, 16 and 36 mL/m2, and 46% and 61%, respectively, for women. Men had significantly larger EDVs, ESVs, and stroke volumes (even after body surface area indexing) and lower EFs than women (P&nbsp

Aims The impact of mitral valve geometry on outcomes after MitraClip treatment in secondary mitral regurgitation (MR) has not been examined. We therefore sought to evaluate the association between mitral valve geometry and outcomes of patients with heart failure (HF) and secondary MR treated with guideline-directed medical therapy (GDMT) and MitraClip. Methods and results Mitral valve geometry was assessed from the baseline echocardiograms in 614 patients from the COAPT trial. The primary endpoint for the present study was the composite of all-cause mortality or HF hospitalization (HFH) within 2 years. Effect of treatment arm (MitraClip plus maximally tolerated GDMT vs. GDMT alone) on outcomes according to baseline variables was assessed. Among 29 baseline mitral valve echocardiographic parameters, increasing anteroposterior mitral annular diameter was the only independent predictor of the composite endpoint of all-cause mortality or HFH [adjusted hazard ratio (aHR) per cm 1.49; P = 0.04]. The effective regurgitant orifice area (EROA) was independently associated with all-cause mortality alone (aHR per cm2 2.97; P = 0.04) but not with HFH, whereas increasing anteroposterior mitral annular diameter was independently associated with HFH alone (aHR per cm 1.85; P = 0.005) but not all-cause mortality. Other mitral valve morphologic parameters were unrelated to outcomes. MitraClip reduced HFH and mortality independent of anteroposterior mitral annular diameter and EROA (Pinteraction = 0.77 and 0.27, respectively). Conclusion In patients with HF and severe secondary MR, a large anteroposterior mitral annular diameter and greater EROA were the strongest echocardiographic predictors of HFH and death in patients treated with GDMT alone and with the MitraClip.

Objectives The aim of this study was to determine the prognostic impact of right ventricular (RV)–pulmonary arterial (PA) coupling in patients with heart failure (HF) with severe secondary mitral regurgitation (SMR) enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. Background RV contractile function and PA pressures influence outcomes in patients with SMR, but the impact of RV-PA coupling in patients randomized to transcatheter edge-to-edge repair (TEER) vs guideline-directed medical therapy (GDMT) is unknown. Methods RV-PA coupling was assessed by the ratio of RV free wall longitudinal strain derived from speckle-tracking echocardiography and noninvasively measured RV systolic pressure. Advanced RV-PA uncoupling was defined as RV free wall longitudinal strain/RV systolic pressure ≤0.5%/mm Hg. The primary endpoint was a composite of all-cause mortality or HF hospitalization at 24-month follow-up. Results A total of 372 patients underwent speckle-tracking echocardiography, and 70.2% had advanced RV-PA uncoupling. By multivariable analysis, advanced RV-PA uncoupling was strongly associated with an increased risk for the primary 24-month endpoint of death or HF hospitalization (HR: 1.87; 95% CI: 1.31-2.66; P = 0.0005). A similar association was present for all-cause mortality alone (HR: 2.57; 95% CI: 1.54-4.29; P = 0.0003). The impact of RV-PA uncoupling was consistent in patients randomized to TEER and GDMT alone. Compared with GDMT alone, the addition of TEER improved 2-year outcomes in patients with (48.0% vs 74.8%; HR: 0.51; 95% CI: 0.37-0.71) and those without (28.8% vs 47.8%; HR: 0.51; 95% CI: 0.27-0.97) advanced RV-PA uncoupling (Pinteraction = 0.98). Conclusions In the COAPT trial, advanced RV dysfunction assessed by RV-PA uncoupling was a powerful predictor of 2-year adverse outcomes in patients with HF and SMR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079 )

OBJECTIVE To evaluate how variation in the way patient satisfaction feedback is delivered relates to physician well-being and perceptions of its impact on patient care, job satisfaction, and clinical decision making. PARTICIPANTS AND METHODS A cross-sectional electronic survey was sent to faculty physicians from a large academic medical center in March 29, 2019. Physicians reported their exposure to feedback (timing, performance relative to peers, or channel) and related perceptions. The Professional Fulfillment Index captured burnout and professional fulfillment. Associations between feedback characteristics and well-being or perceived impact were tested using analysis of variance or logistic regression adjusted for covariates. RESULTS Of 1016 survey respondents, 569 (56.0%) reported receiving patient satisfaction feedback. Among those receiving feedback, 303 (53.2%) did not believe that this feedback improved patient care. Compared with physicians who never received feedback, those who received any type of feedback had higher professional fulfillment scores (mean, 6.6±2.1 vs 6.3±2.0; P=.03) but also reported an unfavorable impact on clinical decision making (odds ratio [OR], 2.9; 95% CI, 1.8 to 4.7; P